Nanotechnology Faces FDA Hurdles

Global interest in nanotechnology is expanding, anticipated to go to a $3 trillion industry for enabled products by 2015, and President Barack Obama's budget includes $1.8 billion for research and development. But with great market power comes an even more difficult challenge of FDA regulation for these products for the medical device industry.

Mary Gray, manager of regulatory affairs at DePuy Synthes/Johnson & Johnson, addressed the issue at MD&M West on Tuesday during a panel, saying that the various substances that go into nanotechnology can make it a key-enabling tech that can be significantly cheaper and higher performing than other technology currently available on the market.

Nanotechnology is a multidisciplinary science that can help manipulate matter on an atomic and molecular scale to potentially create adhesives, super-hydrophobic materials, and anti-fouling materials for medical devices. The materials used in this typically range from 1 to 100 nanometers – which means it’s smaller than bacteria, but greater than a molecule of water. What people would define as nanotechnology has been arguably been used for hundreds of years in the food and cosmetic industries.

Applying these surfaces to biotechnology, according to Gray, could enhance clinical outcomes and optimize biological responses for many different medical devices. With the National Nanotechnology Initiative, 26 federal agencies are looking at it to see what could result from further use of the technology, including FDA.

However, according to Gray, it is unclear how many of the agencies will bring it in, let alone how FDA will regulate it. The CDRH classifies nanotechnology as a “new science,” and looks at instances where it is used on a case-by-case basis. Multiple medical bodies over the world are currently exploring regulations, including the EU, Canada, and International Standard Organizations.

There is a certain amount of scientific uncertainty in nanotechnology for medical devices, including regulatory resource constraints. “There’s enough as it is,” Gray says. “There will be more with this.”

There may also be environmental issues that could come up with the exploration of this technology in a new usage, including concerns that certain nanotechnology materials could have a negative impact on human health or the environment as a result of their new properties.

No matter the usage of new developments, it’s more important than ever for device developers to pay attention to what is in their products, particularly as they are going to FDA regulation. Sissy Ann Tschernoscha, quality systems supervisor for NuSil Silicone Technology in Carpenteria, Calif., said that this is not an uncommon problem that her company faces.

With many submission processes taking an extended period of time, she finds that many of the company’s customers don’t address the extra regulation process that comes with the materials used in nanotechnology ahead of time. She said that customers often come to them with their rejection letters, she says that many of them have not addressed the raw materials involved.

“We, as the suppliers, are often times surprised that they didn’t address them earlier,” she said. “If you haven’t explored it, start thinking about it.”